BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 15498594 · Received September 28, 2022

    Report

    Report Number
    2916596-2022-13908
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    July 1, 2020
    Report Date
    September 27, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR#2916596-2022-02063 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON 12SEP2022 THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. : EVENT DATE IS ESTIMATED MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ELEVATION IN LDH ON AN UNKNOWN DATE, ESTIMATED TO BE (B)(6) 2020, FOLLOWED BY ANOTHER OCCURRENCE ON (B)(6) 2020. IN BOTH CASES, THE ISSUE WAS TREATED WITH LOW MOLECULAR WEIGHT HEPARIN AND THE PATIENT¿S PUMP SPEED WAS INCREASED TO 8800RPM. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. HMII LVAS IFU LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS, INCLUDING HEMOLYSIS. THE PATIENT CARE AND MANAGEMENT SECTION PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE RELEVANT SECTIONS OF THE DEVICE HISTORY WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INCREASE IN LACTATE DEHYDROGENASE (LDH) AND TREATMENT WAS PERFORMED BY FLUID REPLACEMENT, AN ADMINISTRATION OF LOW-MOLECULAR WEIGHT HEPARIN, AND AN INCREASE IN PUMP SPEED TO 8800 REVOLUTIONS PER MINUTE (RPM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583638 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 5896361 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention